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NCT03630952 Clinical Trial

Efficacy and Safety Trial of Conbercept Intravitreal Injection for Neovascular AMD (PANDA-2)

Neovascular Age-related Macular Degeneration Clinical Trial

Official title:
A Multicenter, Double-Masked, Randomized, Dose-Ranging Trial to Evaluate the Efficacy and Safety of Conbercept Intravitreal Injection in Subjects With Neovascular Age-Related Macular Degeneration (AMD) (PANDA-2)

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03630952
Other study ID # KHB-1802
Secondary ID
Status Terminated
Phase Phase 3
First received
Last updated
Start date December 21, 2018
Est. completion date May 19, 2021

Study information
Verified date June 2021
Source Chengdu Kanghong Biotech Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this clinical study is to evaluate the efficacy and safety of two different levels of conbercept intravitreal (IVT) injection as compared to the approved vascular endothelial growth factor (VEGF) antagonist active control, aflibercept intravitreal injection (2.0 mg/eye, Eylea®), in subjects with neovascular AMD.

Description:

A multicenter, multinational, double-masked, parallel-group, dose-ranging, active-controlled, randomized trial, which will randomize approximately 1140 subjects in a ratio of 1:1:1 to receive IVT injections of 0.5 mg conbercept, 1.0 mg conbercept, or 2.0 mg aflibercept. The trial includes a screening period of less than or equal to 14 days, followed by a treatment period of 92 weeks (last assessment at 96 weeks) with primary efficacy analysis at 36 weeks.

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Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• 0.5 mg Conbercept Intravitreal Injection
Subjects received 0.5 mg conbercept intravitreal injection at Day 1, Week 4 and Week 8 (three injection loading dose), and treated every eight weeks thereafter (0.5 mg, q8w) through Week 36. At the Week 40 visit, the criteria-based pro re nata (PRN) approach will begin through the end of the treatment period at Week 92, for a total of 92 weeks treatment in the study eye.
• 1.0 mg Conbercept Intravitreal Injection
Subjects received 1.0 mg conbercept intravitreal injection at Day 1, Week 4 and Week 8 (three injection loading dose), and treated every twelve weeks thereafter (1.0 mg, q12w) through Week 36. At the Week 40 visit, the criteria-based PRN approach will begin through the end of the treatment period at Week 92, for a total of 92 weeks treatment in the study eye.
• 2.0 mg Aflibercept Intravitreal Injection
Subjects received 2.0 mg aflibercept intravitreal injection at Day 1, Week 4 and Week 8 (three injection loading dose), and treated every eight weeks thereafter (2.0 mg, q8w) through Week 36. At the Week 40 visit, the criteria-based PRN approach will begin through the end of the treatment period at Week 92, for a total of 92 weeks treatment in the study eye.
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Sponsors (1)
Lead Sponsor Collaborator
Chengdu Kanghong Biotech Co., Ltd.

Countries where clinical trial is conducted

United States,  Bulgaria,  China,  Czechia,  Denmark,  France,  Hungary,  Israel,  Italy,  Latvia,  Slovakia,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mean change from baseline in best corrected visual acuity (BCVA) at Week 36 in the study eye BCVA was assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) method Baseline to Week 36
Secondary Proportion of subjects maintaining vision (i.e., losing <15 ETDRS BCVA letters) from baseline to Week 36 To Assess Proportion of subjects maintaining vision (i.e., losing <15 ETDRS BCVA letters) from baseline to Week 36 Baseline to Week 36
Secondary Proportion of subjects gaining =15 ETDRS BCVA letters from baseline to Week 36 To Assess Proportion of subjects gaining =15 ETDRS BCVA letters from baseline to Week 36 Baseline to Week 36
Secondary Mean change from baseline in central retinal thickness (µm) by spectral domain optical coherence tomography (SD-OCT) at Week To Assess Mean change from baseline in central retinal thickness (µm) by spectral domain optical coherence tomography (SD-OCT) at Week Baseline and Week 36
Secondary Proportion of subjects maintaining vision (i.e. losing <15 ETDRS BCVA letters) from baseline to Week 48 To Assess Proportion of subjects maintaining vision (i.e. losing <15 ETDRS BCVA letters) from baseline to Week 48 Baseline to Week 48
Secondary Mean change from baseline in ETDRS BCVA letter score at Week 96 To Assess Mean change from baseline in ETDRS BCVA letter score at Week 96 Baseline and Week 96
Secondary Number of participants with adverse events as measure of safety and tolerability To Assess Number of participants with adverse events as measure of safety and tolerability Baseline to Week 96
Secondary Blood concentration of conbercept doses conducted in a subgroup of subjects, when feasible To Assess Blood concentration of conbercept doses conducted in a subgroup of subjects, when feasible Baseline to Week 96
Secondary Half-life (t1/2) of conbercept doses conducted in a subgroup of subjects, when feasible To Assess Half-life (t1/2) of conbercept doses conducted in a subgroup of subjects, when feasible Baseline to Week 96
Secondary Presence of anti-drug antibody of conbercept doses conducted in a subgroup of subjects, when feasible To Assess Presence of anti-drug antibody of conbercept doses conducted in a subgroup of subjects, when feasible Baseline to Week 96
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